HUTCHMED said AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for ORPATHYS plus TAGRISSO in locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification after progression on EGFR tyrosine kinase inhibitor therapy.

The application is supported by SAFFRON, a global Phase III trial in 338 patients that compared the combination with doublet platinum-based chemotherapy. HUTCHMED said the study showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival, with no new safety concerns.

For traders and newer investors, the immediate takeaway is limited to the regulatory step itself: the company is seeking US approval for a biomarker-directed, all-oral treatment option, and it said the regulatory review remains under way. HUTCHMED also said the results will be presented in a Presidential Symposium at the upcoming European Society for Medical Oncology Congress 2026.

HUTCHMED said ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.

Highlights

  • The filing seeks approval for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification after EGFR-TKI therapy.
  • SAFFRON found the combination beat doublet platinum-based chemotherapy on progression-free survival and overall survival.
  • HUTCHMED said the results will be presented at the European Society for Medical Oncology Congress 2026.